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Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
35
Latest Decision
1981-11-24

Clearances · page 143 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813005 KODAK CINEFLUOROGRAPHIC FILM SO-274 Eastman Kodak Company IWZ Class I 1981-11-24
K812791 PORTABLE MEDICAL TABLE Richard D. Spradlin KXJ Class II 1981-11-24
K812915 MX 125 General Electric Co. ITY Class I 1981-11-24
K813032 ZIKON 100 DIGITAL X-RAY SYSTEM Kontron Instruments, Inc. JAB Class II 1981-11-24
K811842 IMAGER 2000 REAL TIME SYSTEM Siemens Gammasonics, Inc. IYO Class II 1981-11-20
K812301 VARIABLE FOCUS 3.5 MHZ TRANSDUCER Adr Ultrasound ITX Class II 1981-11-16
K812743 FETAL VITABILITY TM MODE Technicare Corp. IYO Class II 1981-11-16
K812398 LINUS Fischer Imaging Corp. IYO Class II 1981-11-10
K812775 FLUORICON L300 IMAGE INTENSIFIER General Electric Co. JAA Class II 1981-11-06
K812726 KERMATH THERAPY SIMULATOR Kermath Mfg. Corp. KPQ Class II 1981-11-05
K812721 DIGITRON Siemens Corp. IZI Class II 1981-11-04
K812535 PLASTILIX MINIRAD D CASSETTE Eastman Kodak Company IXA Class II 1981-10-19
K812588 SCANNER 700 National Ultrasound Corp. IYO Class II 1981-10-19
K812561 LATERAL ANGULATING FLUORO SUSPENSION SYS General Electric Co. JAA Class II 1981-10-13
K812616 POLYPHOS 500 Siemens Corp. IZO Class I 1981-10-13
K812606 SECTORTAC Echo Laboratories, Inc. IYN Class II 1981-10-13
K812393 4001 CT SCANNER Omnimedical JAK Class II 1981-10-13
K812509 CT/T 8800 General Electric Co. JAK Class II 1981-10-13
K812400 OMNIMEDICAL QUAD I Omnimedical JAK Class II 1981-10-02
K812410 DELTASCAN 2060 CT SCANNER Technicare Corp. JAK Class II 1981-10-02
K812337 ISOCENTRIC NEUTRON THERAPY SYSTEMS The Cyclotron Corp. IWL Class II 1981-10-02
K812332 KERMATH L/C ARM Kermath Mfg. Corp. KPR Class II 1981-09-16
K812217 FLUORO AUTOMATIC BRIGHTNESS SYS Keystone X-Ray, Inc. JAA Class II 1981-09-16
K812014 DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING Elscint, Inc. IYO Class II 1981-09-16
K812238 D.I.V.A.S. Cgr Medical Corp. IZI Class II 1981-09-11
K812235 GOLD(AU 195) SPOT MARKER SOURCES Amersham Corp. IXD Class I 1981-09-09
K812152 MEDI VIEW Medical Synergy IXC Class I 1981-09-09
K812236 GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD) Amersham Corp. IYO Class II 1981-09-09
K812241 CT/T 9800 General Electric Co. JAK Class II 1981-09-09
K811629 DYNA- MO Philips Medical Systems (Cleveland), Inc. IYX Class I 1981-09-08
K812088 POLAROID RADIOGRAPHIC FILM PROCESSOR Polaroid Corp. IXW Class II 1981-08-31
K811843 BIOPSY TRANSDUCER Siemens Gammasonics, Inc. ITX Class II 1981-08-25
K810660 KREMER CORNEOMETER ULTRASONIC PACHOMETER Accutome, Inc. IYO Class II 1981-08-21
K811426 ARTICULATED ARM B-SCANNER General Electric Co. IYO Class II 1981-08-18
K812032 MEVATRON 67E Siemens Medical Laboratories, Inc. IYE Class II 1981-08-18
K811931 NEEDLE GUIDE ATTACHMENT Technicare Corp. IYO Class II 1981-08-18
K811969 DUAL PEDESTAL TABLE Philips Medical Systems (Cleveland), Inc. KXJ Class II 1981-08-13
K811970 AP X-RAY TUBE ANGULATION DEVICE Philips Medical Systems (Cleveland), Inc. IYB Class I 1981-08-13
K811967 CP-625 SEE-THRU FILM CHANGER Philips Medical Systems (Cleveland), Inc. KPX Class II 1981-08-13
K812024 XEROX 128 CASSETTE CHANGER Xerox Medical Systems KPX Class II 1981-08-13
K811934 DSS 500 Philips Medical Systems (Cleveland), Inc. KPR Class II 1981-08-13
K811807 UROSKOP C Siemens Corp. KPR Class II 1981-08-10
K811572 ATL'S MARK 100/300 ULTRASOUND SYSTEMS Advanced Technology Laboratories, Inc. IYO Class II 1981-08-10
K811252 MS-50 ULTRASONIC IMAGER Kontron Instruments, Inc. IYO Class II 1981-08-07
K811094 CARDIAC 1000 TM American Edwards Laboratories JAA Class II 1981-07-28
K811778 MODEL 4100 14 MEV NEUTRON GEN. THERAPY The Cyclotron Corp. IWL Class II 1981-07-23
K811723 WHOLE BODY SCANNER Cgr Medical Corp. JAK Class II 1981-07-20
K811715 ROTA CAMERA Siemens Gammasonics, Inc. IYX Class I 1981-07-20
K811633 CIRAS ULTRASONIC SCANNING SYSTEM Ausonics Pty , Ltd. IYO Class II 1981-07-10
K811227 CT/T DATALINK-B7875 AA/B7875 AB General Electric Co. JAK Class II 1981-07-10
K811587 SIEMENS ANGIOTRON Siemens Corp. IXO Class I 1981-07-10
K811528 RADIATION BOLUS Action Products, Inc. JAD Class II 1981-07-10
K811676 MAXI CAMERA/D General Electric Co. IYX Class I 1981-07-02
K811316 TRISCAN, MODELS 38,40,41,43 & 45 Visidyne Corp. IYO Class II 1981-07-02
K811688 TUNGSTEN SYRINGE SHIELD Medi-Physics Inc. Dba Nycomed Amersham Imaging IWR Class I 1981-07-02
K811677 KRYPTON CART Medi-Physics Inc. Dba Nycomed Amersham Imaging KPY Class I 1981-07-02
K811450 ALUMINUM FILTRATION SYSTEM Wedge Filtration System KPW Class II 1981-07-02
K811198 ECCO GENERATOR Philips Medical Systems (Cleveland), Inc. IZO Class I 1981-06-29
K811302 SOMATOM 2N Siemens Corp. IZF Class II 1981-06-23
K811295 DIGITAL NOISE REDUCER Philips Medical Systems (Cleveland), Inc. JAA Class II 1981-06-23
K811230 X-CELL X-RAY #'S P-75W/P-75M X-Cel X-Ray Corp. KPR Class II 1981-06-23
K810748 7.5 MHZ WP TRANSDUCER General Electric Co. ITX Class II 1981-06-19
K811352 POLAROID TPX RADIOGRAPHIC FILM Polaroid Corp. IWZ Class I 1981-06-18
K811211 YOSHIDA AP 100 Kaycor Intl., Ltd. EGY Class II 1981-06-16
K811215 KERMATH RADIOGRAPHIC HEAD STAND Kermath Mfg. Corp. KPR Class II 1981-06-12
K811142 BELMONT PODIATRY MODEL 065 X-RAY Belmont Equipment Corp. KPR Class II 1981-06-09
K811195 ARGOSTAT Tecnomed, Inc. IYB Class I 1981-06-09
K811196 ALLMEC 90/15 Tecnomed, Inc. KXJ Class II 1981-06-09
K811197 SUPERIX 120 Tecnomed, Inc. IZF Class II 1981-06-09
K810133 ULTRAPROBE Ars Magna IYN Class II 1981-06-09
K811149 PANDOROS 1200A Siemens Corp. IZI Class II 1981-06-09
K811118 KRYPTON MASKS & TUBING Medi-Physics Inc. Dba Nycomed Amersham Imaging IYT Class II 1981-06-02
K811320 CAL-3 CALIBRATED RADIOACTIVITY ASSAYER Dosimeter Corp. KPT Class II 1981-06-02
K811358 DEHYDRATED BILE Acumedia Manufacturers, Inc. JAK Class II 1981-05-29
K811187 MEDTRONIC A2 CLINICAL IMAGING SYSTEM Medtronic Vascular IYX Class I 1981-05-27
K811068 BYPASS COIL G.D. Searle and Co. KPY Class I 1981-05-27
K810973 SYSTEM 400 Philips Medical Systems (Cleveland), Inc. KPR Class II 1981-05-21
K811082 BETA I & BETA II Porta Ray, Inc. IZL Class II 1981-05-21
K810858 XIMATRON V Siemens Corp. KPQ Class II 1981-05-13
K810974 GAMMA CAMERA Siemens Gammasonics, Inc. IYX Class I 1981-05-13
K810945 SCANEL 100 Cgr Medical Corp. IYO Class II 1981-05-08
K810914 5CM SMALL PARTS SCANNER Smithkline Diagnostics, Inc. IYO Class II 1981-05-08
K810873 STAR Intl. General Electric Co. JWM Class II 1981-04-23
K802635 OPHTHALMO ECHOGRAPH MODEL ZD255G Jedmed Instrument Co. IYO Class II 1981-04-23
K810716 X-RAY IMAGE INTENSIFIER PRODUCTS Instrumentation Camera, Inc. JAA Class II 1981-04-23
K810749 5 MHZ TRANSDUCER General Electric Co. ITX Class II 1981-04-17
K810038 DIGITAL DIAGNOSTIC ULTRASOUND DEVICE Rohe Scientific Corp. IYO Class II 1981-04-17
K810819 MEDI/NUCLEAR #XE-102 XENON/MASTER Medi Nuclear Corp., Inc. IYT Class II 1981-04-14
K810797 LOW DOSE SERVOCHEST Philips Medical Systems (Cleveland), Inc. KPR Class II 1981-04-14
K810598 X-RAY COLLIMATING DEVICES Midmark Corp. IZW Class II 1981-04-10
K810588 SYNCHRONIZER #208 Brattle Instrument Corp. IXO Class I 1981-04-10
K810589 NEURO-ECAT Eg&G Ortec, Inc. KPS Class II 1981-04-10
K810590 P.R.M. 80 T.E.M. Instruments , Ltd. IZW Class II 1981-04-10
K810276 ALPHA I AND ALPHA II Porta Ray, Inc. IZL Class II 1981-03-11
K810274 CLINIX-R TOMOGRAPHIC DEVICE Philips Medical Systems (Cleveland), Inc. IZF Class II 1981-03-11
K810307 ZONOGRAPH 6 Siemens Corp. IZF Class II 1981-03-11
K810364 DIGITAL RADIOGRAPHY SYSTEM Adac Laboratories JAA Class II 1981-03-11
K810073 MARK 500 SYSTEM Advanced Technology Laboratories, Inc. IYO Class II 1981-03-05
K803049 DIGITAL RADIOGRAPHY CHEST DEVICE Philips Medical Systems (Cleveland), Inc. KPR Class II 1981-03-02
K810189 SIRECON COMPACT Siemens Corp. JAA Class II 1981-03-02

14,721 clearances in the Radiology panel. Data: openFDA.